Sealed back pressure breathing device

ABSTRACT

A hand-held breathing device for use by patients having respiratory problems creates a sealed backpressure in the airways of the patient by creating resistance to exhalation. A peep valve is mounted inside a hollow body, and a pre-set compression spring is mounted between the valve and an adjustable cap or cam lever in the main body of the device. A pair of valve openings extend through the wall of the main body, one opening serving as an intake port for inhaling of air by the patient and the second port—for exhalation of carbon dioxide. An intake valve is mounted inside the body between a normally open end of the device and the exhalation valve. In one of the embodiments, the device is attached to a nebulizer to facilitate buildup of positive pressure and delivery of medication to the patients&#39; lungs.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation of my co-pending applicationSer. No. 09/699,226 filed on Oct. 26, 2000 for “Sealed Back PressureBreathing Device,” which is a continuation-in-part of my jointapplication, Ser. No. 09/471,553, filed on Dec. 23, 1999, entitled“Sealed Back Pressure Attachment Device for Nebulizer,” now U.S. Pat.No. 6,412,481, the full disclosures of which are incorporated byreference herein.

BACKGROUND OF INVENTION

[0002] The present invention relates to a device for assisting pulmonaryfunctions of a patient; it can be used alone for exercising musclesinvolved in breathing or in combination with a nebulizer for delivery ofmedication to the airways of a patient. More particularly, the presentinvention relates to a breathing device for generating positivebackpressure in the airways of the user so as to keep the airways openand restore normal breathing.

[0003] Nebulizers are some of the most widely used devices for assistingpatients with breathing problems; they help deliver medication duringasthma attacks, emphysema attacks and similar occasions. Nebulizers areconventionally used in emergency rooms, by patients, and medicalprofessionals when conventional method metered dose inhalers (MDIs) failto reverse a constriction in the airways. The nebulizers break down theliquid medicine into tiny droplets that resemble mist and then deliverthe medication into the lungs and airways of the patient.

[0004] Conventionally, nebulizers dispense airway dilators. For example,when a patient is brought into an emergency room, he has an unusuallyhigh concentration of carbon dioxide in blood. The nebulizer helpsdeliver the much-needed dilators to the lungs and help expel the gasfrom the lungs. The dilators contain a chemical that reacts with thereceptors in the bronchioles of the patient to open the airways. Themedications may include steroids, magnesium sulfate, andbronchodilators.

[0005] However, conventional nebulizers are relatively slow, it mayrequire up to eight hours of treatment. When a patient arrives in anacute condition that requires an immediate treatment, an ambu bag with amask is often used. The mask seals the moth and nose of the patient;when the bag is squeezed positive pressure forces the medication intothe airways. This procedure is not free from complications. Air may bediverted into the patient's stomach and cause gastric distention orvomiting, which in turn increases the risk of aspiration since thevomited medium may be inhaled and forced into the lungs.

[0006] Some patients cannot be helped with either nebulizers or ambubags; they require a ventilator, an artificial breathing machine thatworks with an endotracheal tube inserted into the trachea of thepatient. The positive pressure is much greater than when nebulizer withan ambu bag are used. Often times, excessive air is forced into thepatient's lungs. The longer a patient stays on a ventilator, the moredifficult it may be to wean the patient from ventilator. Prolonged useof the ventilator tends to cause atrophy of inspiratory muscles, whichmay become irreversible.

[0007] This invention contemplates elimination of drawbacks associatedwith the prior art and provision of hand-held devices that can beequally used by the patient and by a medical professional for exercisinginspiratory muscles and for delivery of medication with the help of anebulizer.

SUMMARY OF THE INVENTION

[0008] It is, therefore, an object of the present invention to provide asealed calibrated back pressure device that would allow creation ofpositive pressure on the constricted airways of a patient suffering fromasthma, emphysema or other respiratory diseases.

[0009] It is another object of the present invention to provide a sealedback pressure breathing attachment device for a nebulizer that can bepreset to create the desired amount of pressure and deliver themedication for restoring the patient's breathing.

[0010] It is a further object of the present invention to provide abreathing device that would help in exercising inspiratory muscles of apatient.

[0011] These and other objects of the present invention are achievedthrough a provision of a hand-held lightweight device that has a meansfor adjusting the amount of positive pressure created in the airways ofthe patient. The device has a hollow body with a peep valve mounted on abracket inside the hollow body. The hollow body is provided with twothrough openings: an intake port and an exhalation port. An intakevalve, which can be as simple as a rubber gasket, is mounted in thehollow body between the exhalation valve and an open end.

[0012] The open end may carry a mouthpiece or be suitably sized andshaped to be connected, via a manifold, to a nebulizer. The oppositeclosed end of the hollow body carries a means for adjusting the positivepressure. In one of the embodiments, the adjustment means is a cap thatthreadably engages the hollow body; in the second embodiment—it is anadjustable cam lever. A compression spring is mounted between theexhalation valve and the adjustment means. The calibration may be set toa desired pressure, preferably between 5 cm and 20 cm of water.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Reference will now be made to the drawings, wherein like partsare designated by like numerals, and wherein FIG. 1 is a perspectiveview of the attachment device in accordance with the first embodiment ofthe present invention.

[0014]FIG. 2 is a longitudinal sectional view of the device shown inFIG. 1 showing the adjustable cap threadably engaged with the main body.

[0015]FIG. 3 is a longitudinal sectional view of the device of the firstembodiment, with the adjustable cap being separated from the main body.

[0016]FIG. 4 is a perspective view of the second embodiment of thedevice in accordance with the present invention mounted on a manifoldthat connects the device to a nebulizer.

[0017]FIG. 5 is a longitudinal sectional view showing the embodiment ofFIG. 4 with an adjustable cam lever.

[0018]FIG. 6 is a longitudinal sectional view of the second embodimentshowing air movement on inspiration and expiration.

[0019]FIG. 7 is a detail view showing a support bracket on theexpiration valve.

[0020]FIG. 8 is a detail front view showing the intake open on theexhalation valve.

[0021]FIG. 9 is a detail view showing an intake valve.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0022] Turning now to the drawings in more detail, numeral 10 designatesthe device in accordance with the first embodiment of the presentinvention. The device 10 comprises an elongated main hollow body 12having a first cylindrical portion 14, a unitary connected middleconical portion 16, and a mouthpiece 18, which is unitary connected tothe middle portion 16. A central opening 20 is formed in the body 12,extending from the mouthpiece opening 22, through the mouthpiece 18,conical portion 16, and the main body 14.

[0023] An adjustable screw cap 24 closes the normally closed end 26 ofthe main body portion 14. The cap 24 is provided with threads 28 on theinner wall of the cap. The threads 28 matingly engage with threads 30 onthe exterior wall of the end 26. A central plug 32 is formed in the cap24, the plug 32 extending outwardly from an inner end 34 of the cap 24.The end 34, as can be better seen in FIG. 3, forms an annular shoulderthat provides a first abutting surface, against which a compressionspring 40 abuts, as will be described in more detail below.

[0024] An intake port 42 is cut through the wall of the hollow body 12,and an exhalation port 44 is formed in the main body portion 14, at alocation spaced apart from the intake port 42. Positioned between theports 42 and 44 is an exhalation peep valve 50, which is shown in anopen intake position in more detail in FIG. 7. The valve 50 is the samevalve that is used in the first and second embodiments of the presentinvention; therefore, its description will be omitted when the secondembodiment is described hereinafter.

[0025] The exhalation valve 50 is mounted on a support bracket, or frame52 that is fitted inside the main body portion 14. The support bracket52 is provided with an annular flange 54 that frictionally engages theinner wall of the main portion 14. The inner corner of the flange 54provides a second abutting surface for the compression spring 40.

[0026] An inwardly extending shoulder 56 is formed on the inner wall ofthe main portion 14 adjacent to the area of connection between the mainportion 14 and the conical portion 16. The shoulder forms a stop whenthe bracket 52, along with the peep valve 50 is forced against theshoulder 56.

[0027] An intake valve 60 (FIG. 9) is mounted in the main portion 14between an open end 22 and the bracket 52. The intake valve 60 can be assimple as a flexible rubber gasket that forms a one-way valve that opensduring inhalation. The diameter of the circular intake valve 60 issmaller than the inner diameter of the opening 20 in the main portion14, allowing some air to move around the intake valve 60. The intakevalve, or flap 60 is made from a flexible material, for example latex.The flap lays over the ports of the piston/bracket 52 when pressure isagainst the piston and against the spring 40, but flaps open through theopenings in the bracket allowing intake of fresh air.

[0028] When the device 10 is assembled, the spring 40 abuts, at one ofits ends, against the inner end, or shoulder 34, around the plug 32. Thesecond end of the spring 40 abuts against the valve 50 mounted in thebracket 52, normally forcing the peep valve in a closed position shownin FIG. 2. The valve opens on intake of air, as shown in FIG. 8, butoffers the pre-set resistance to a gas flow during exhalation.

[0029] When the user needs to exercise the muscles or simply distendairways, he closes his lips around the open end 22 of the mouthpiece 18.During inhalation, the air travels from the intake port 42, through thevalve 50, around the valve 60, and into the open end 22 of themouthpiece 18. On exhalation, the flow of gas is reversed, moving fromthe open end 22, around the valve 60, and against the resistance of thecompression spring 40, into the directional exhalation port 44. In orderfor exhalation gas to exit the body 12, the user must exert sufficientpressure on the spring 40 to move the bracket 52 into a position awayfrom the exit port 44 to allow the gas to be expelled.

[0030] Since the spring 40 offers resistance to the opening of the peepvalve 50, a positive back pressure is created in the airways of thepatient, forcing the patient to apply more force in exhaling, therebystrengthening the muscles involved in breathing. The cap 24, being incontact with the spring 40 can be screwed more or less tightly on thebody 12, allowing adjustment for creation of positive pressure in therange of 5 cm to 20 cm of water. This range was found sufficient formost of the patients, although other pressure adjustments may be easilymade if desired.

[0031] Turning now to the second embodiment shown in FIGS. 4-6, thenebulizer attachment device 70 is illustrated. The device 70 comprisesan elongated, generally cylindrical body 72 that has a normally open end74 and a normally closed end 76. An adjustable cam lever 78 is securedto a shaft connected to a piston 94 mounted in the end 76 to allowadjustment of the pressure required for opening and closing of the peepvalve mounted inside the body 72. The pressure may be adjusted to adesired value, for example in the range of 5 cm to 10 cm of water,depending on the user's condition.

[0032] The adjustment may be accomplished by regulating position of thelever. For example, a first position would indicate pressure of 5 cm ofwater. By flipping the lever in an opposite direction, the user mayregulate compression of the spring to create pressure of about 10 cm ofwater. Of course, the movement of the cam lever 78 may be calibrated toany pressure in between the desired range, setting different positionson the body 72 and indicating the setting by suitable indicia.

[0033] The body 72 is provided with a directional intake port 80 and adirectional exhalation port 82. The open end 74 is adapted forfrictional engagement with a manifold 84 that carries a mouthpiece 86and a conventional nebulizer 88. The manifold 84, mouthpiece 86, andnebulizer 88 are not part of this invention; they are shown in phantomlines in FIG. 4.

[0034] Referring now to FIGS. 5 and 6, the interior of the device 70 isshown in more detail. As can be seen in FIG. 5, the body 72 is providedwith a central opening 90 that extends from the open end 74 to theclosing wall 92 of the closed end 76. The cam lever 78 is rotatablymounted on a shaft 77 (FIG. 6) that is fixedly attached to the wall 92of the closed end 76. The piston 94 moves a small distance within thecentral opening 90 only to adjust compression of a spring 96.

[0035] The compression spring 96 is mounted between the piston member 94and the exhalation valve peep valve 98. The valve 98 is similar is allrespects to the valve 50 and, therefore its detail description isomitted here. The exhalation peep valve 98 allows creation of positiveback pressure by forcing the patient to exhale against the force of thecompressed spring 96. An intake valve, similar to the valve 60 is in thebody 72 between the open end 74 and the valve 98.

[0036] During intake of air, the air travels through the port 80,through the valve 98 and intake valve 60 in the direction of arrow 100.During exhalation, or expiration, the air moves against the rubbergasket, or flap valve 60 that normally closes the ports of thepiston/bracket. By continuing exhalation, the patient is able to movethe bracket, against resistance of the compression spring 96, away fromthe exhalation port 82, allowing the gas to move through the exhalationpeep valve 98 and through the exhalation port 82, in the direction ofarrow 102, as shown in FIG. 6.

[0037] Once the adjustable cam lever 78 is set for the desiredresistance to air movement, the device 70 is mounted on the manifold 84and becomes connected to the nebulizer 88. A quantity of medication 104deposited in the nebulizer 88 mixes with the air passing through themanifold 84 to the mouthpiece 86 and is delivered to the airways of thepatient. The tiny droplets of medication dispersed by theaerosol-forming member 106 intercept the airflow passing through thebody 72. The formed mist mixes with the intake airflow and is deliveredinto the airways of the user, extending the airways and reducing theasthma attack or other breathing problems of the patient.

[0038] It is preferred that during exhalation or inhalation, thepatients keep their mouths firmly closed around mouthpieces 18 and 86,so as to seal the open ends of the devices 10 and 70 and to alloweffective delivery of medication and exhalation of gases. When thepatient exhales, the peep valve tends to distend airways of the patientand prevent collapsing of the alveoli by creating a positive backpressure.

[0039] When the air is forced to exit only through the exhalation valvethat has been pre-set to offer resistance by a cap 24 or by the cam 78,the exhaust airflow cannot exit through the intake port and has to movethrough the exhalation ports 44 or 82. By keeping a sealed positivebackpressure in the devices 10 and 70, the airways of the patients arekept open restoring the normal breathing. Once the pressure inside theinflamed sac is equalized with the pressure in a trachea, the medicationhas a much better chance to penetrating deep into the airways and causedilation.

[0040] The devices 10 and 70 allow trapped carbon dioxide to escapethrough the exhalation ports 44 or 82, thereby reducing the toxic levelsof carbon dioxide into the blood stream of the user. When the trappedgases are removed from the lungs, the lungs can then generate a greaterinspiratory pressure with less effort of the patient.

[0041] Once the airways are extended, the pyramid effect establishesitself thus increasing the flow of much needed oxygenated air. The user,allowing pressure equalization and increase of volume in all lung areas,experiences a long expiratory phase. Once the airways are extended, theair movement into and out of the lungs is considerably improved. Thelungs are not hyper-inflated; fresh air enters the lungs with more ease.

[0042] Additionally, if the attachment 70 is used, the medicine 104 ispulled in from the nebulizer 88 more effectively to reach the affectedareas of the lungs and further dilate the airways. Consequently, thepatient's collapsed or obstructed airways remain open and more precisemedication delivery may be achieved. The treatment then becomes moreeffective with less medication.

[0043] The present invention can be used for patients suffering fromasthma or emphysema. Many patients suffering from asthma have unexpectedattacks and difficulty of getting to their medication. The attack may beenhanced by anxiety that the patient would suffocate before getting themedication. By having a small portable device readily available, thepatient can at least restore some breathing and reduce the anxietyfactor.

[0044] During an emphysema attack, the terminal bronchioles are weakenedand are in a permanently enlarged condition. The alveolar walls areoften times damaged. Because of the loss of alveolar space, the amountof surface area for gas exchange is reduced, and the elastic recoil ofthe lung tissue is diminished.

[0045] It is the lack of elasticity that causes inadequate lung recoiland fatigues inspiratory muscles. The lungs are unable to properly relaxand return to their normal position. Under such conditions, patients areoften advised to breathe with “pursed lips.” By using, the sealed backpressure devices 10 or 70, that emphysema sufferers can increasedelivery of air into the lungs and exhaust the carbon dioxide from theblood stream.

[0046] The backpressure created by the devices 10 and 70 prevents -thebronchioles, alveoli from collapsing. The reduction of resultanthyperinflation allows the patient to inspire and exhale more fully,thereby delivering medication to a greater surface of the damagedtissue. Additionally, the sealed back pressure helps to keep the alveoliand airways open, allowing the release of the carbon dioxide from thelungs into the atmosphere. The effective removal of gas from the lungsand the blood stream improves the physiological function of the patientand allows more oxygen to be delivered into the lungs.

[0047] It is envisioned that the valve 10 and 70 can be preset togreater values than indicated above, particularly with patients havingconsiderable problems with collapsed airways, although the preferredsettings would range from about 5 cm to 20 cm of water.

[0048] It is envisioned that the devices of the present invention may beused for exercising the patients and restoring their ability to normallybreathe. This is particularly true with a device 10 of the firstembodiment. It is also envisioned that a nose clip and/or a moldedcushioned mouthpiece may be used in combination with the mouthpieces toensure a better seal of the patients' lips around the mouthpiece.

[0049] The device of the present invention can be inexpensivelymanufactured from readily available materials, such as plastic andlightweight metal. The springs 40 and 96 will naturally be manufacturedfrom a material that is strong enough to withstand multiple compressionsand expansions during use of the device. It is envisioned that themouthpiece 18 may be manufactured to detachably engage the main bodyportion 14, if desired. In such a case, the device 10 with separatedmouthpiece 18 may be carried in a compact space, such as the user'spocket, and engaged with the rest of the device, when needed.

[0050] The device 70 may be attached to a metered dose inhaler (MDI),instead of a nebulizer, if necessary. In such a case, a mini spacerwould be used instead of the manifold 84. The mini spacer conventionallyhas a port for delivery of medication, for example anti-inflammatorydrugs, in the form of a fine mist.

[0051] Many changes and modifications may be made in the design of thepresent invention without departing from the spirit thereof. I,therefore, pray that my rights to the present invention be limited onlyby the scope of the appended claims.

I claim:
 1. A sealed back pressure device for assisting a respiratoryfunction of a patient, comprising: an elongated hollow body having afirst normally open end, a second normally closed end, an intake portand an exhalation port; a one-way exhalation valve mounted inside thehollow body for allowing exhaust gas to be exhaled through theexhalation port; a compression spring mounted between the exhalationvalve and the closed end for regulating resistance to gas flow beingexhaled by the patient; and a means mounted on the second end of thehollow body for adjusting compression of the spring.
 2. The device ofclaim 1, wherein said adjusting means comprises a cap detachably mountedon the second end, said cap providing a first abutting surface for saidcompression spring.
 3. The device of claim 2, wherein said exhalationvalve is supported by a frame mounted in the hollow body, said frameproviding a second abutting surface for said compression spring.
 4. Thedevice of claim 2, wherein said cap is threadably engageable with thesecond end of the hollow body.
 5. The device of claim 2, wherein saidcap adjustably compresses said compression spring to maintain a positiveback pressure of between 5 and 20 centimeters of water.
 6. The device ofclaim 3, wherein said hollow body is provided with an annular shoulderextending into a central opening formed by the hollow body, and whereinsaid frame contacts said shoulder, thereby preventing sliding movementof the frame toward said open end.
 7. The device of claim 1, whereinsaid open end is provided with a mouthpiece for engagement by lips ofthe patient.
 8. The device of claim 1, further comprising an intakevalve mounted between said open end and said exhalation valve.
 9. Thedevice of claim 8, wherein said intake valve comprises a rubber gasket.10. The device of claim of claim 1, wherein said adjusting meanscomprises a sliding piston movable inside said hollow body, said pistonproviding an abutment surface for said compression spring.
 11. Thedevice of claim 9, wherein an adjustable cam lever is mounted on saidpiston for adjusting resistance to an exhalation gas flow.
 12. Thedevice of claim 10, wherein said cam lever is adjustable to maintain apositive back pressure in the range of between 5 and 10 centimeters ofwater.
 13. The device of claim 1, wherein said hollow body is adaptedfor attachment to a nebulizer for establishing fluid communicationbetween said hollow body and the nebulizer for delivery of medication toairways of the patient.
 14. The device of claim 13, wherein said openend of the hollow body is detachably securable to the nebulizer.
 15. Asealed back pressure device for assisting respiratory functions of apatient, comprising: an elongated hollow body having a first normallyopen end, a second normally closed end, an intake port and an exhalationport; a one-way exhalation valve carried by a supporting bracket andmounted inside the hollow body for allowing exhaust gas to be exhaledthrough the exhalation port; a compression spring mounted between theexhalation valve and the closed end for maintaining a positive backpressure and regulating resistance to gas flow being exhaled by thepatient; and a means mounted on the second end of the hollow body foradjusting compression of the spring, said adjusting means comprising acap detachably mounted on the second end, said cap providing a firstabutting surface for said compression spring, said support bracketproviding a second abutting surface for said compression spring.
 16. Thedevice of claim 15, wherein said open end is provided with a mouthpiecefor engagement by lips of the patient.
 17. The device of claim 15,further comprising an intake valve mounted between said open end andsaid exhalation valve.
 18. The device of claim 15, wherein said cap isthreadably engageable with the second end of the hollow body.
 19. Thedevice of claim 15, wherein said cap adjustably compresses saidcompression spring to maintain a positive back pressure of between 5 and20 centimeters of water.
 20. The device of claim 15, wherein said hollowbody is provided with an annular shoulder extending into a centralopening formed by the hollow body, and wherein said support bracketcontacts said shoulder, thereby preventing sliding movement of thesupport bracket toward said open end.
 21. A sealed back pressure devicefor assisting respiratory functions of a patient, comprising: anelongated hollow body having a first normally open end, a secondnormally closed end, an intake port and an exhalation port; a one-wayexhalation valve carried by a supporting bracket and mounted inside thehollow body for allowing exhaust gas to be exhaled through theexhalation port; a compression spring mounted between the exhalationvalve and the closed end for maintaining a positive back pressure andregulating resistance to gas flow being exhaled by the patient; and ameans mounted on the second end of the hollow body for adjustingcompression of the spring, said adjusting means comprising a slidingpiston movable inside said hollow body, said piston providing a firstabutment surface for said compression spring and said support bracketproviding a second abutting surface for said compression spring.
 22. Thedevice of claim 21, wherein an adjustable cam lever is mounted on saidpiston for adjusting resistance to an exhalation gas flow.
 23. Thedevice of claim 22, wherein said cam lever is adjustable to maintain apositive back pressure in the range of between 5 and 10 centimeters ofwater.
 24. The device of claim 21, wherein said hollow body is adaptedfor attachment to a nebulizer for establishing fluid communicationbetween said hollow body and the nebulizer for delivery of medication toairways of the patient.
 25. The device of claim 24, wherein said openend of the hollow body is detachably securable to the nebulizer.